Can a state ban a drug that has the federal government’s seal of approval?
The answer could come as soon as Monday in a Massachusetts courtroom, where a federal judge is expected to rule on Gov. Deval L. Patrick’s recent decision to prohibit the sale of a powerful new painkiller approved last fall by the Food and Drug Administration.
Last month, citing a “public health emergency” prompted by rising deaths due to drug addiction, Patrick (D) barred Zohydro, a controversial prescription drug composed of a pure dose of hydrocodone, the main ingredient in the painkiller Vicodin. Critics say that the drug, which hit the market in March, invites abuse because of its potent formula and lack of tamper-resistant features.
Patrick’s move is an aggressive, if novel, effort to slow the toll caused by widespread abuse of opioids, which include prescription medications such as OxyContin and illegal substances such as heroin. Prescription-drug overdoses have risen steadily over the past decade and account for an estimated 16,000 deaths a year in the United States.
The FDA has faced a backlash since approving Zohydro over the objections of an outside advisory panel, which voted 11 to 2 to recommend rejection of the drug. Lawmakers from both parties have urged the Obama administration to reconsider the FDA decision. Dozens of state attorneys general have warned that the drug could undermine years of work in fighting the nation’s prescription-drug epidemic.
Vermont Gov. Peter Shumlin (D) this month issued an emergency order intended to make it harder for doctors to prescribe Zohydro. Some hospitals have refused to stock the drug. But no place has taken more drastic measures than Massachusetts.
Patrick argued that the prohibition on Zohydro was justified because it poses serious risks to addicts and to those who might become addicted. “We have an epidemic of opiate abuse in Massachusetts, so we will treat it like the public health crisis it is,” he said in announcing his decision.
“To our knowledge, this is the first time it’s ever happened, that a state has banned an FDA-approved drug,” said Heather Gray, a legislative attorney for the nonprofit National Alliance for Model State Drug Laws.
Gray cited the legalization of marijuana in Colorado and Washington as instances in which states have permitted substances that remain illegal on the federal level. But rarely, if ever, has a state forbidden the sale of a medication approved by federal regulators.
“If states start taking it into their own hands, deciding what to allow or not allow citizens in their own states to take, that could cause problems,” Gray said. “What if you have another governor who says, ‘I’m Catholic, and I don’t like contraception, so I’m not going to allow physicians in my state to prescribe contraceptives’? I don’t think it will get to that point, but that’s an example of what potentially could happen.”
Zogenix, the California-based maker of Zohydro, filed suit in federal court, arguing that Patrick’s ban violated its constitutional rights and that federal regulators have deemed the drug safe and effective. The company said it took legal action after it didn’t get an answer to a request to meet with the governor.
In a hearing last week, U.S. District Judge Rya W. Zobel seemed strongly inclined to side with Zogenix, noting that the state could not attribute the
prescription-drug epidemic to Zohydro, which has yet to be distributed. “I think, frankly, the governor is out of line on this,” said Zobel, according to a Boston Globe account that described the judge as “irritated.”
She gave lawyers until Monday to prepare more detailed arguments on the case, after which Zobel is expected to issue a decision.
Outside the courthouse, Zogenix chief executive Stephen J. Farr told reporters that Patrick’s order “was harming our company, certainly hurting the patients of Massachusetts.”
In a brief interview, FDA Commissioner Margaret Hamburg seemed to agree, saying that although addiction is a “huge concern” with opiate drugs, “it’s concerning when either a state, or Congress, steps in to make decisions about what drugs should be approved or what drugs should be withdrawn from the marketplace.”
Prior to Zohydro, hydrocodone medications were available only in formulations that included nonaddictive pain medications, such as acetaminophen. Proponents of Zohydro say that the pure hydrocodone form will allow chronic pain suffers to take the drug long term, without the risk of liver damage. But critics argue that such a formulation also makes the drug easier to abuse, particularly because it doesn’t yet come in a tamper-
resistant version. They say that makes the pills, which are intended to release the medication slowly, susceptible to being crushed and ingested all at once.
Massachusetts Public Health Commissioner Cheryl Bartlett said that officials didn’t take the Zohydro ban lightly. Rather, she said, the decision came out of months of discussions about ways to combat the growing number of deaths linked to heroin and prescription drug overdoses — and out of a sense that the state should take whatever measures it could to prevent more harm.
“The idea that a new drug would come on the market that would add to the problems just didn’t seem to make sense,” Bartlett said. “We’re not denying people pain medication. There are plenty of alternatives. We’re addressing another public health crisis.”